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Multi-agent Low Dose Chemotherapy GAX-CI Followed by Olaparib and Pembro in Metastatic Pancreatic Ductal Cancer. | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Multi-agent Low Dose Chemotherapy GAX-CI Followed by Olaparib and Pembro in Metastatic Pancreatic Ductal Cancer.

Multi-agent Low Dose Chemotherapy (Gemcitabine, Nab-paclitaxel, Capecitabine, Cisplatin, Irinotecan) Followed by Maintenance Olaparib and Pembrolizumab in Untreated Metastatic Pancreatic Ductal Adenocarcinoma.

NCT04753879•Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety and clinical activity of maintenance olaparib and pembrolizumab following multi-agent, low dose chemotherapy with gemcitabine, nab-paclitaxel, capecitabine, cisplatin, and irinotecan (GAX-CI) in patients with untreated metastatic pancreatic ductal cancer.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Cohort 1 - Subject has stable disease as measured by RECIST 1.1 or iRECIST after 6 cycles of GAX-CI.
•Cohort 2 - Subject has progressive disease as measured by RECIST 1.1 and iRECIST prior to 6 cycles of GAX-CI.
•Ability to understand and willingness to sign a written informed consent document.
•Age ≥18 years.
•Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
•Have metastatic histologically or cytologically-proven ductal pancreatic cancer.
•Patients must not have received prior treatment for pancreatic cancer.
•Have measurable disease based on RECIST 1.1.
•Willing to have to a tumor biopsy.
•Patients must have adequate organ and marrow function defined by study - specified laboratory tests.
+3 more criteria

Exclusion Criteria

•Patients who will be considered for surgery are ineligible.
•Had chemotherapy within 5 years prior to study treatment.
•Have received any investigational drugs within 28 days prior to study treatment.
•Had surgery within 28 days of dosing of investigational agent.
•Has history of central nervous system (CNS) metastases and/or carcinomatous meningitis.
•Require any antineoplastic therapy.
•Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent.
•Has received prior therapy with gemcitabine, nab-paclitaxel, capecitabine, cisplatin, irinotecan, or PARP inhibitor.
•Hypersensitivity reaction to any monoclonal antibody.
•Is taking a moderate or strong CYP3A inhibitor.
+19 more criteria

Locations (1)

Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

Key Dates

Start Date

September 29, 2021

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2029

Last Updated

December 4, 2025

Enrollment

ESTIMATED participants

Conditions

Metastatic Pancreatic Cancer

Interventions

Nab-paclitaxel

DRUG

Gemcitabine

DRUG

Cisplatin

DRUG

Irinotecan

DRUG

Capecitabine

DRUG

Pembrolizumab

DRUG

Olaparib

DRUG

Contacts

Colleen Apostal, RN

CONTACT

410-614-3644 GIClinicaltrials@jhmi.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Multi-agent Low Dose Chemotherapy GAX-CI Followed by Olaparib and Pembro in Metastatic Pancreatic Ductal Cancer.

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer

Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients

Nab-Paclitaxel + Cisplatin + Gemcitabine + TTF in pt. w/ Metastatic PAC

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